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Economic and Social Disparities and Breast Cancer (DESSEIN)

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ClinicalTrials.gov Identifier: NCT02948478
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
National Cancer Institute, France
Paris West University Nanterre La Défense
Paris 12 Val de Marne University
Fondation Ophtalmologique Adolphe de Rothschild
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Precariousness is a multifactorial concept that can be broken down in the form of economic insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has an impact on health that is difficult to assess precisely because it also impacts on other factors that may themselves influence health. Therefore, the understanding of the impact of precariousness on health involves studying individuals in their context.

Our study is designed to assess the impact of precariousness on the history of breast cancer, on care pathways, on treatment and rehabilitation in a multidisciplinary contextual analysis. Indeed, the socio -economic and geographical inequalities affect the history of breast cancer, treatment and its delay and post- treatment rehabilitation.

The main objective of this project is to compare the stage of disease at diagnosis (according to the TNM classification) in deprived and non deprived patients. The secondary objectives are to compare in the two groups - the socio-economic and geographical inequalities - the direct and indirect costs related to the management, the out-of pocket costs and to describe, based on individual inequalities identified, the pathway of care of the patient.

These objectives will be pursued in the framework of an observational cohort study, prospective, multicenter (Ile de France) comparative exposed / unexposed category. Each precarious patient will be matched to a non- precarious patient in the same age group, regardless of the center. The study will include any patient resident in Ile de France seeking treatment for breast cancer, regardless of the stage.


Condition or disease Intervention/treatment
Breast Cancer Other: Exposed Other: Non exposed

Detailed Description:

All patients seeking treatment for breast cancer, regardless of the stage, can be included in the study. Three scores of precariousness will be applied to all patients (EPICES score, Pascal score and the European Deprivation Index). Patients identified as precarious by at least one of those three scales will be in the exposed group. The others will be in the non-exposed group.

Baseline assessment T0:

Are required only the clinical examination and radiological evaluation with the tumor size and node involvement according to TNM classification. A questionnaire will be distributed including EPICES score, Pascal score and European Deprivation Index. The baseline questionnaire will also assess the socio-economic characteristics of patients and the care trajectory before arriving in the center (see appendix).

Follow-up visits:

The following questionnaire will be distributed during a consultation that is scheduled in the routine care. There will be no additional consultation imposed on the patient.

  • T1: questionnaire at 3 months after inclusion
  • T2: questionnaire at 6 months after inclusion
  • T3: questionnaire at 12 months after inclusion

Questionnaires will be focused on direct-costs and out-of-pocket costs, socio-economical characteristics, rehabilitation, return to work.

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Study Type : Observational
Estimated Enrollment : 1040 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Breast Cancer and Precariousness: Influence of Socio-demographic Inequalities in Cancer Stage at Diagnosis, Treatment Management and Rehabilitation in the Ile de France Area
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Precarious patients
Precarious patients - exposed - will be those identified as precarious by at least one of the three scores (EPICES, Pascal, European Deprivation Index)
Other: Exposed
Precarious patients

Non precarious patients
Non precarious patient - non exposed - will be all the patients identified as non-precarious by the three scores (EPICES, Pascal, European Deprivation Index)
Other: Non exposed
Non precarious patients




Primary Outcome Measures :
  1. TNM stage [ Time Frame: Baseline ]
    TNM classification according to initial clinical and radiological assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from Ile de France area having a breast cancer histologically proved and seeking for treatment. Any patient consulting for the first time in a specialized center for the treatment of breast cancer in Ile de France, whatever the stage of the disease, may potentially be recruited.
Criteria

Inclusion Criteria:

- Patients ? 18 years old having a breast cancer histologically proved

Exclusion Criteria:

- Patients with a history of cancer treated in the previous five years, or with another associated untreated cancer


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948478


Contacts
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Contact: Charlotte NGO, MD 0033 1 56 09 54 14 charlotte.ngo@aphp.fr
Contact: Hakima MANSEUR, MSc 0033 156095971 hakima.manseur@aphp.fr

Locations
Show Show 24 study locations
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Cancer Institute, France
Paris West University Nanterre La Défense
Paris 12 Val de Marne University
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Charlotte NGO, MD AP - HP, Hôpital Européen Georges-Pompidou, Paris, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02948478    
Other Study ID Numbers: K160202
ID RCB 2016-A00589-42 ( Other Identifier: Agence Nationale de Sécurité du Médicament et des Produits de Santé )
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
precariousness
care pathways
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases